Devices and methods for preventing distal embolization using flow reversal by partial occlusion of the brachiocephalic artery

ABSTRACT

The invention provides a medical device having a catheter and one or more expandable constricting/occluding members. The catheter is adapted for use with therapeutic or diagnostic devices, including an angioplasty/stent catheter and an atherectomy catheter. The constrictor/occluder is mounted at the distal end of the catheter. Manometers may be mounted distal to one or more constrictors for measuring pressure distal to the constrictor(s). Methods of using the devices for preventing distal embolization during extracranial or intracranial carotid procedures or vertebral artery procedures by reversing blood flow in an internal carotid artery, an external carotid artery, and/or a common carotid artery toward the subclavian artery are disclosed.

This is a divisional of U.S. application Ser. No. 10/614,439, filed Jul.2, 2003 now U.S. Pat. No. 6,837,881, which is a divisional of U.S.application Ser. No. 09/792,600, filed Feb. 23, 2001, now U.S. Pat. No.6,595,980, both of which are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods useful intreating patients with stroke or occlusive cerebrovascular disease. Morespecifically, the invention provides an extracranial device capable ofreversing flow down a vertebral artery, an internal carotid artery, anexternal carotid artery and/or a common carotid artery, and into thesubclavian artery during an invasive procedure, thereby avoiding distalembolization of vascular debris. Various diagnostic or therapeuticinstruments, including an atherectomy catheter, a filter, and/or anangioplasty/stent catheter, can be introduced through the device fortreating the occlusion. The invention may also be useful to reverse flowand pull back embolic debris during a stroke.

BACKGROUND OF THE INVENTION

Stroke is the third most common cause of death in the United States andthe most disabling neurologic disorder. Approximately 700,000 patientssuffer from stroke annually. Stroke is a syndrome characterized by theacute onset of a neurological deficit that persists for at least 24hours, reflecting focal involvement of the central nervous system, andis the result of a disturbance of the cerebral circulation. When apatient presents neurological symptoms and signs that resolve completelywithin 1 hour, the term transient ischemic attack (TIA) is used.Etiologically, TIA and stroke share the same pathophysiologic mechanismsand thus represent a continuum based on persistence of symptoms andextent of ischemic insult.

Outcome following stroke is influenced by a number of factors, the mostimportant being the nature and severity of the resulting neurologicdeficit. Overall, less than 80% of patients with stroke survive for atleast 1 month, and approximately 35% have been cited for the 10-yearsurvival rates. Of patients who survive the acute period, up to 75%regain independent function, while approximately 15% requireinstitutional care.

Hemorrhagic stroke accounts for 20% of the annual stroke population.Hemorrhagic stroke often occurs due to rupture of an aneurysm orarteriovenous malformation bleeding into the brain tissue, resulting incerebral infarction. The remaining 80% of the stroke population arehemispheric ischemic strokes and are caused by occluded vessels thatdeprive the brain of oxygen-carrying blood. Ischemic strokes are oftencaused by emboli or pieces of thrombotic tissue that have dislodged fromother body sites or from the cerebral vessels themselves to occlude inthe narrow cerebral arteries more distally. The extracranial orintracranial internal carotid artery, commonly affected byatherosclerosis causing symptomatic occlusion in the arterial lumen, isoften responsible for hemispheric ischemic stroke and generatingthromboembolic material downstream to the distal cerebral vessels.Treatment of the occluded carotid artery in patients with stroke and TIAor for stroke prevention inpatients with asymptomatic flow limitingcarotid stenosis includes performing angioplasty, stent placement, oratherectomy on the occluded carotid artery. This is also true of thevertebral artery. Unfortunately, placing instrumentation within adiseased artery is associated with increased risk of ischemic stroke,since manipulation of an atheromatous plaque in the arterial wall oftencauses emboli to dislodge distally in the narrow cerebral arteries.

Current methods of preventing distal embolization from carotidinstrumentation include insertion of a blood filter distal to theocclusion and suctioning embolic debris during the procedures.Disadvantages associated with the conventional methods are that (1)inserting the filter through the atheromatous lesion is associated withincreased risk of distal embolization, (2) using suction to reverse theflow in the internal carotid artery may increase a patient's blood lossif the suctioned blood is discarded, and (3) systemic anticoagulationand pumping may be required to recycle the suctioned blood back into thearterial or venous system, and such anticoagulation is associated withincreased risk of hemorrhage.

New devices and methods are thus needed for patients undergoing carotidprocedures for definitive or prophylactic treatment of carotid plaque,which minimize the risk of distal embolization and prevent ischemicstroke.

SUMMARY OF THE INVENTION

The invention provides devices and methods for preventing ischemicstroke in patients undergoing percutaneous invasive vertebral or carotidprocedures, including angioplasty, stent placement, and/or filterinsertion, by reversing blood flow down a vertebral artery, anextracranial or intracranial internal carotid artery, an externalcarotid artery, and/or a common carotid artery and into the ipsilateralsubclavian artery. In this way, embolic debris generated as a result ofplacing instrumentation within a diseased artery is diverted to thesubclavian artery, thereby preventing stroke by minimizing distalembolization to the narrow cerebral vessels. The devices and methods arealso useful to remove an embolus and improve flow (by reversingcollateral blood flow across the circle of Willis) in patients withacute stroke.

The invention utilizes devices comprising a catheter having one or twoexpandable constricting members at its distal end. Each constrictor maybe a balloon, in certain cases a toroidal balloon, or a device of anyother appropriate shape, so that it can fully or partially occlude bloodflow. The lumen of the catheter may be adapted for insertion of atherapeutic instrument, such as an angioplasty, atherectomy, and/orstent catheter. A manometer is optionally mounted proximal and/or distalto the constricting member for monitoring blood pressure proximal and/ordistal the constrictor.

The occluder/constrictor is mounted near the distal end of the catheter,in certain cases proximal to a port. Each balloon occluder andconstrictor communicates with an inflation lumen and an inflation portat the proximal end of the catheter. In certain embodiments, thecatheter will include first and second constriction/occlusion members.The second constrictor is mounted on a second member that is slideablyinsertable through the catheter, and passes beyond the firstconstrictor. In this way, the second member and the second constrictorare moveable longitudinally relative to the first constrictor. In otherembodiments, the constrictor may consist of a balloon having more thanone opening at its center for the passage of blood, or may consist ofmore than one expandable balloons allowing passage of blood through thegap between the arterial wall and the expanded balloons. The proximalend of the catheter may include a hemostatic valve.

In still another embodiment, the catheter includes a second lumencommunicating with a proximal end and an infusion port at its distalend. The port is located distal to the distal port of the catheter. Thesecond lumen and its port are adapted for delivering a pharmaceuticalagent to the carotid, brachiocephalic and/or subclavian arteries,including an angiographic dye. Any device described in Barbut, U.S. Pat.No. 6,146,370, incorporated herein by reference in its entirety, mayalso be used in the methods described herein.

The invention provides methods for reversing flow in a vertebral orcarotid artery having an atheromatous lesion. More specifically, themethods are useful in reversing flow down a vertebral artery, anextracranial or intracranial internal carotid artery, an externalcarotid artery, and/or a common carotid artery and into the subclavianartery. In a first method, using the devices described above, the distalend of the catheter is inserted into the right brachiocephalic artery.The catheter can be inserted over a guidewire through an incision on aperipheral artery, including the femoral artery, the subclavian artery,or the brachiocephalic artery. The catheter is positioned to locate theconstricting member within the right brachiocephalic artery. Preferably,the constrictor is expanded to completely or partially occlude the rightbrachiocephalic artery. At a critically low brachiocephalic pressuredistal to the constriction, blood flow in the carotid and vertebralarteries is reversed to pass over the atheromatous lesion and into theright subclavian artery. The flow reversal can be verifiedfluoroscopically with dye. If flow reversal fails to occur or ifaugmentation of flow reversal is desired, a second constricting memberis expanded in the right subclavian artery, further reducing thepressure in the subclavian artery to facilitate reversal of flow downthe carotid artery and into the subclavian artery.

In another method, the distal end of the catheter is inserted into theaorta in the takeoff of the left common carotid artery and leftsubclavian artery. The catheter is positioned to locate the constrictingmember within the inlet of the left subclavian artery and the leftcommon carotid artery. The constrictor is expanded to completely orpartially occlude the subclavian and common carotid artery. At acritically low pressure, blood flow in the carotid artery is reversed topass over the atheromatous lesion and into the left subclavian artery.The flow reversal can be verified fluoroscopically with dye. If flowreversal fails to occur or if augmentation of flow reversal is desired,a second constricting member is expanded in the left subclavian artery,further reducing the pressure in the subclavian artery to facilitatereversal of flow down the carotid artery and into the subclavian artery.

In another method, using the device having a second occluder including ashunt for the passage of blood therethrough, the catheter is inserted inthe right brachiocephalic artery, with the first occluder located in theright brachiocephalic artery and the second occluder located in theright subclavian artery. Preferably, the first occluder is expanded toocclude the brachiocephalic artery followed by expansion of the secondoccluder to occlude the subclavian artery. Alternatively, the secondoccluder is expanded to occlude the subclavian artery followed byexpansion of the first occluder to occlude the brachiocephalic artery.

After blood reversal is confirmed, procedures on either the vertebralartery, the internal carotid artery or branches thereof (e.g., MCA orACA), external carotid artery, or common carotid artery can be performedby advancing a therapeutic or diagnostic instrument through the lumenand port of the catheter distal to the occluder. An atherectomycatheter, for example, can be introduced to remove the atheroma in theright internal carotid artery without fear of distal embolization.

It will be understood that there are several advantages in using thedevices and methods disclosed herein for prevention of distalembolization during use of instrumentation in the carotid arteries. Forexample, the devices (1) abolish the need for suction distal to theconstricting/occluding member, thereby minimizing blood loss, (2)eliminate the need for systemic anticoagulation, pumping, and a secondarterial or venous stick, all of which are required where suction isemployed, (3) can be used to introduce a variety of diagnostic ortherapeutic instrument to the carotid artery, (4) can be used in anyprocedures which require instrumentation within the carotid artery, (5)can be used for definitive treatment of acute or subacute ischemicstroke, (6) can be used in the angiogram or fluoroscopy suite availablein most hospitals, (7) require only one incision site for entry, and (8)can be used to perform an interventional procedure without distalprotection (e.g., a distal filter), and without crossing the lesion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts normal cerebral circulation in the Circle of Willis.

FIG. 2 depicts a reversed circulation in the Circle of Willis tocompensate for an occlusion in the left internal carotid artery.

FIG. 3A depicts a distal region of an embodiment of the medical devicehaving an occluding member for prevention of acute stroke during use ofinstrumentation in a carotid artery.

FIG. 3B depicts a distal region of another embodiment of the medicaldevice having a constricting member.

FIG. 4A depicts a distal region of another embodiment of the medicaldevice having a constricting member distal an occluding member.

FIG. 4B depicts a distal region of another embodiment of the devicehaving two manometers.

FIG. 5 depicts the device of FIG. 4B including a hemostatic valve at itsproximal end.

FIG. 5A depicts another embodiment of the device having a proximaloccluder and a distal constrictor.

FIG. 5B depicts another embodiment of the device having a proximalconstrictor and a distal constrictor.

FIG. 5C depicts another embodiment of the device having a proximaloccluder and a distal occluder.

FIG. 5D depicts another embodiment of the device having a proximaloccluder and a distal occluder.

FIG. 6A depicts the device of FIG. 3A inserted in the rightbrachiocephalic artery.

FIG. 6B depicts the expanded occluder causing reversal of blood flowfrom the internal carotid artery to the subclavian artery.

FIG. 6C depicts an angioplasty balloon catheter inserted through thedevice in FIG. 6B to treat an occluding lesion in the right internalcarotid artery.

FIG. 6D depicts the use of an occluder to establish carotid flowreversal and a second balloon to protect the vertebral artery againstembolization.

FIG. 7A depicts the device of FIG. 3B inserted in the rightbrachiocephalic artery.

FIG. 7B depicts the expanded constricting member causing reversal ofblood flow from the common carotid artery to the subclavian artery.

FIG. 7C depicts an atherectomy catheter inserted through the device inFIG. 7B to treat an occluding lesion in the right common carotid artery.

FIG. 8 depicts the device of FIG. 5 inserted in the rightbrachiocephalic artery and the right subclavian artery to increase thepressure gradient between the right common carotid artery and the rightsubclavian artery.

FIG. 9 depicts the constricting member of the device of FIG. 3Bconstricting the inlets of the left common carotid artery and the leftsubclavian artery.

FIG. 10 depicts an occlusion catheter suitable for introduction throughthe right subclavian artery.

FIG. 11 depicts an occlusion catheter capable of bridging between theleft common carotid artery and the left subclavian artery.

FIG. 11 A depicts an aortic constriction catheter capable of causingflow reversal down the left CCA.

FIG. 12 depicts incision sites on various peripheral arteries for theinsertion of the medical devices.

DETAILED DESCRIPTION

The cerebral circulation is regulated in such a way that a constanttotal cerebral blood flow (CBF) is generally maintained under varyingconditions. For example, a reduction in flow to one part of the brain,such as in stroke, may be compensated by an increase in flow to anotherpart, so that CBF to any one region of the brain remains unchanged. Moreimportantly, when one part of the brain becomes ischemic due to avascular occlusion, the brain compensates by increasing blood flow tothe ischemic area through its collateral circulation via the Circle ofWillis.

FIG. 1 depicts a normal cerebral circulation and formation of Circle ofWillis. Aorta 100 gives rise to right brachiocephalic trunk 82, leftcommon carotid artery (CCA) 80, and left subclavian artery 84. Thebrachiocephalic artery further branches into right common carotid artery85 and right subclavian artery 83. The left CCA gives rise to leftinternal carotid artery (ICA) 90 which becomes left middle cerebralartery (MCA) 97 and left anterior cerebral artery (ACA) 99. Anteriorly,the Circle of Willis is formed by the internal carotid arteries, theanterior cerebral arteries, and anterior communicating artery 91 whichconnects the two ACAS. The right and left ICA also send right posteriorcommunicating artery 72 and left posterior communicating artery 95 toconnect respectively with right posterior cerebral artery (PCA) 74 andleft PCA 94. The two posterior communicating arteries and PCAs, and theorigin of the posterior cerebral from basilar artery 92 complete thecircle posteriorly. The left CCA also gives rise to external carotidartery (ECA) 78, which branches extensively to supply most of thestructures of the head except the brain and the contents of the orbit.The ECA also helps supply structures in the neck.

When occluding lesion 70 occurs acutely, for example, in left internalcarotid artery 90, as depicted in FIG. 2, blood flow in the rightcerebral arteries, left external carotid artery 78, right vertebralartery 76, and left vertebral artery 77 increases, resulting in adirectional change of flow through the Circle of Willis to compensatefor the sudden decrease of blood flow in the left internal carotidartery. Specifically, blood flow reverses in right posteriorcommunicating artery 72, right PCA 74, and left posterior communicatingartery 95. Anterior communicating artery 91 opens, reversing flow inleft ACA 99, and flow increases in the left external carotid artery,reversing flow along left ophthalmic artery 75, all of which contributeto flow in left ICA 90 distal to the occluding lesion.

Balloon catheters for achieving flow reversal in carotid arteries weredescribed in Barbut, U.S. Pat. No. 6,146,370, incorporated herein byreference in its entirety. FIG. 3A depicts one embodiment of the devicefor preventing distal embolization during use of carotidinstrumentation. The device comprises catheter 1 and balloon occluder10. The catheter has lumen 5 communicating with a proximal end and port6 at a distal end. The lumen and port are adapted for introduction oftherapeutic or diagnostic instruments, e.g., an atherectomy catheter,angioplasty catheter, and stent, to a carotid artery. Balloon occluder10, communicating with inflation lumen 11, is mounted on the distal endof the catheter proximal to port 6. Manometer 15 is mounted distal tooccluder 10 for monitoring blood pressure downstream the occluder.

FIG. 3B depicts another embodiment of the device having constrictingmember 20 mounted on a distal region of the catheter proximal to port 6.Constricting member 20 communicates with inflation lumen 21. Theconstrictor has central opening 22 that allows passage of blood.Manometer 15 is mounted distal to constrictor 20 for monitoring bloodpressure downstream the constrictor.

FIG. 4A depicts another embodiment of the device comprising catheter 1,balloon occluder 10, and constrictor 20. Lumen 5 of the cathetercommunicates with port 6 at distal end 7. The lumen and port are adaptedfor introduction of therapeutic or diagnostic instruments. Balloonoccluder 10, communicating with inflation lumen 11, is mounted on thedistal end of the catheter proximal to port 6. Balloon constrictor 20,communicating with inflation lumen 21, is mounted distal to port 6 andfirst occluder 10. The constrictor has central opening 22 that allowspassage of blood. Inflation lumen 21 is an elongate member which, incertain embodiments, is slidably inserted through catheter 1, and ismoveable longitudinally relative to catheter 1 and occluder 10.

FIG. 4B depicts another embodiment of the device having two manometers.Manometer 15 is mounted distal to occluder 10 for measuring bloodpressure between the occluder and the constrictor. Manometer 25 ismounted distal to constrictor 20 for measuring blood pressure downstreamfrom constrictor 20. Any of the manometers of any device describedherein will be understood to include a tube communicating with apressure gauge at the proximal end of the catheter.

In FIG. 5, proximal ends 14 and 24 of respective manometers 15 and 25are connected to pressure monitor 16 for measuring blood pressureproximal and distal the constrictor. Inflation ports 13 and 23communicate, respectively, with inflation lumens 11 and 21 for expandingballoon occluder 10 and constrictor 20. Lumen 5 of the cathetercommunicates with proximal end 2, which includes hemostatic valve 19.

FIGS. 5A, 513, 5C, and 5D depict alternative devices for use in theinventions described herein. Each catheter has first balloon 10 andsecond balloon 20. All combinations of constrictors and occluders arecontemplated. Thus, first balloon 10 may be an occluder, and secondballoon 20 may be a constrictor (FIG. 5A). Alternatively, first balloon10 may be a constrictor, and second balloon 20 may be a constrictor(FIG. 5B). Alternatively, first balloon 10 may be a constrictor, andsecond balloon 20 may be an occluder (FIG. 5C). Alternatively, firstballoon 10 may be an occluder, and second balloon 20 may be an occluder(FIG. 5D).

In using the device of FIG. 3A to treat an occluding lesion in the rightinternal carotid artery, for example, a percutaneous incision is firstmade on a peripheral artery, such as the femoral artery. A guidewire isinserted through the incision into the right brachiocephalic artery inan antegrade direction. Alternatively, the guidewire is inserted intothe right brachiocephalic artery from an incision in the left subclavianartery or left brachial artery in a retrograde direction, or in aretrograde direction through the right subclavian artery. The distal endof the catheter is inserted over the guidewire, so that occluder 10 ispositioned in right brachiocephalic artery 82 as shown in FIG. 6A; whereneeded, a guiding catheter can also be used. The guidewire is thenremoved from the catheter.

Occluder 10 is slowly expanded to constrict right brachiocephalic artery82, causing progressive decline in right brachiocephalic and CCApressure as shown in FIG. 6B. The pressure in right brachiocephalicartery 82 distal to occluder 10 can be measured by manometer 15. At acritically low pressure in the brachiocephalic artery, blood flow inright ICA 86 and CCA 85 reverses down toward the brachiocephalic arteryand into right subclavian artery 83. The reversal of blood flow down theCCA and up the subclavian artery can be verified fluoroscopically withdye.

After blood reversal is established from the CCA to the subclavianartery, the devices and methods described above can be used in anycarotid procedures. For example, in FIG. 6C, interventional catheter 30carrying angioplasty balloon 31 is introduced through lumen 5 and port 6of the device. The angioplasty balloon is shown expanding overatheromatous lesion 70 in right ICA 86, thereby compressing the lesionand enlarging the lumenal diameter. Compression of the atheroma by theangioplasty balloon often generates embolic debris, including calcium,atheromatous plaque, and thrombi. With reversal of blood flow from theICA to the CCA and into the right subclavian artery, distal embolizationto the intracranial cerebral arteries is avoided, thereby minimizingrisk of ischemic stroke. Distal embolization of the branches of thesubclavian artery has far less devastating consequences than the ICA.Blood flow through the affected subclavian artery and its branches isreduced but not abolished due to collateral circulation. For example,collateral flow is established from right vertebral artery 203 intoright subclavian artery 83, and this flow reversal in the vertebralartery protects against infarction in the posterior circulation,including the brain stem. In the event that flow reversal does not occurin the vertebral artery upon brachiocephalic occlusion, second balloon204 (see FIG. 6D) is positioned within the takeoff to the vertebralartery to protect against infarction in the posterior circulation.

In using the device of FIG. 3B to treat an occluding lesion in the rightcommon carotid artery, for example, the distal end of the device isfirst inserted into right brachiocephalic artery 82 as shown in FIG. 7A.Constricting member 22 is then expanded to constrict the lumen of thebrachiocephalic artery, causing reversal of blood flow from right CCA 85toward brachiocephalic artery 82 and into right subclavian artery 83 asshown in FIG. 7B. After reversal of blood flow is verifiedangiographically, a therapeutic instrument, such as an atherectomycatheter as depicted in FIG. 7C, is inserted through lumen 5 and port 6to treat the occluding lesion. Embolic debris generated during theprocedure is diverted from CCA 85 toward subclavian artery 83, therebypreventing distal cerebral embolization and ischemic stroke. Theconstruction of atherectomy catheters is well known in the art and willnot be repeated in detail here. The reader is referred instead toFischell, U.S. Pat. No. 5,409,454; Fischell, U.S. Pat. No. 4,898,575;Rydell, U.S. Pat. No. 4,857,045; Yock, U.S. Pat. Nos. 4,794,931,5,000,185, and 5,313,949; Jang et al., U.S. Pat. No. 5,507,292; Farr,U.S. Pat. Nos. 4,950,277, 4,986,807, 5,019,088; Shiber, U.S. Pat. Nos.4,894,051, 4,957,482, 4,979,939, 5,007,896, 5,024,651, 5,135,531;Summers, U.S. Pat. No. 5,087,265; Plassche et al., U.S. Pat. No.5,318,576; Belknap, U.S. Pat. No. 5,366,464; Jang et al., U.S. Pat. No.5,402,790; Mazur et al., Catherization and Cardiovascular Diagnosis31:79-84 (1994); Fischell et al., U.S. Pat. Nos. 4,886,061, 5,100,425;and Barbut et al., U.S. Pat. No. 5,662,671, all of which areincorporated herein by reference as if fully set forth herein. In otherembodiments, catheter 35 may carry angioplasty balloon 36 or a stent.

If flow reversal does not occur due to insufficient blood flow fromcontralateral circulation to the CCA, i.e., an insufficient pressuregradient between the CCA and the subclavian artery, the device of FIG. 5is useful to increase the pressure gradient between the CCA and thesubclavian artery as shown in FIG. 8. In use, the distal end of thedevice is inserted into right brachiocephalic artery 82. The separationbetween occluder 10 and constrictor 20 is adjusted to ensure properplacement in the respective arteries. Preferably, occluder 10 is slowlyexpanded through inflation lumen 11 to constrict brachiocephalic artery82, causing progressive decline of pressure in the subclavian artery.The pressure in the subclavian artery distal to the constrictor and thepressure in the subclavian artery distal to the occluder can bemeasured, respectively, by manometers 25 and 15. At a critically lowpressure in the distal brachiocephalic artery, blood flow in CCA 85reverses toward the brachiocephalic artery and into the subclavianartery. The reversal of blood flow down the CCA and up the subclavianartery can be verified fluoroscopically with dye. If flow reversal doesnot occur due to insufficient pressure gradient between the CCA and thesubclavian artery, constrictor 20 is gradually expanded to furtherreduce the pressure in the subclavian artery to create a more favorablepressure gradient between the CCA and the subclavian artery to reverseblood flow into the subclavian artery.

In treating an occluding lesion in the left common carotid artery, thedevice of FIG. 3B is shown inserted in the inlets of left CCA 80 andleft subclavian artery 84 as depicted in FIG. 9. Occluding member 10 isexpanded to limit blood flow from the aorta into the CCA and thesubclavian artery. After blood flow reverses from left CCA 80 and intoleft subclavian artery 84, a therapeutic instrument, such as a stent isinserted through lumen 5 and port 6. The stent is shown deployed overthe atheromatous lesion in CCA 80, thereby compressing the lesion andenlarging the lumenal diameter. With reversal of blood flow from the CCAto the subclavian artery, distal embolization of debris generated bycompression of the atheromatous lesion to the intracranial cerebralarteries is avoided, thereby minimizing risk of ischemic stroke.

FIG. 11 depicts an alternative embodiment wherein first and secondoccluding members 10 are expanded to occlude each of the left CCA andleft subclavian artery. Flow reversal from left CCA 80 to leftsubclavian 84 is established through tubular member 202 mounted at thedistal end of catheter 1. Interventional catheter is deployed throughtubular member 202 into left CCA 80. In certain embodiments, a thirdballoon (not shown) will be used to block the flow of emboli into theleft vertebral artery. Flow reversal from left CCA 80 to left subclavian84 can also be accomplished by placing constricting member 10 in theaorta between the brachiocephalic artery and the left CCA as shown inFIG. 11 A.

FIG. 10 depicts the use of a catheter adapted for retrograde insertioninto the right subclavian artery. Occlusion member 10 is expanded in theright brachiocephalic artery to establish flow reversal from the rightCCA to the right subclavian. Catheter 30, here an angioplasty catheter,is advanced through port 201 to access stenosis 70 in right ICA 86.

FIG. 12 depicts different sites of entry for the devices disclosedherein. An incision can be made on a peripheral artery, such as rightfemoral artery 122, left femoral artery 120, right brachial artery 112,left brachial artery 110, right axillary artery 126, left axillaryartery 115, right subclavian artery 142, or left subclavian artery 140.

The length of catheter will generally be between 10 and 200 centimeters,preferably approximately between 30 and 150 centimeters. The innerdiameter of the catheter lumen will generally be between 0.2 and 0.8centimeters, preferably approximately between 0.3 and 0.5 centimeters.The diameter of the expanded occluder will generally be between 0.3 and2 centimeters, preferably approximately 0.5 and 1.0 centimeters. Theforegoing ranges are set forth solely for the purpose of illustratingtypical device dimensions. The actual dimensions of a device constructedaccording to the principles of the present invention may obviously varyoutside of the listed ranges without departing from those basicprinciples.

Although the foregoing invention has, for the purposes of clarity andunderstanding, been described in some detail by way of illustration andexample, it will be obvious that certain changes and modifications maybe practiced which will still fall within the scope of the appendedclaims. For example, the devices and features depicted in any depictedembodiment can be used in any other depicted embodiment.

1. A method for reversing flow in a carotid artery, comprising the stepsof: providing a catheter having a proximal end, a distal end, and anelongate tubular member at the distal end, the elongate tubular memberhaving a first constricting member at a proximal end and a secondconstricting member at a distal end; inserting the first constrictingmember into a left common carotid artery; inserting the secondconstricting member into a left subclavian artery; and expanding thefirst and second constricting members, wherein blood flow in the leftcommon carotid artery is reversed to pass through the elongate tubularmember and into the left subclavian artery.
 2. The method of claim 1,further comprising the step of advancing a therapeutic instrument intothe left common carotid artery, a left internal carotid artery, or aleft external carotid artery to reduce a lesion.
 3. The method of claim2, wherein the therapeutic instrument is a stent catheter.
 4. The methodof claim 2, wherein the catheter has a lumen adapted to pass thetherapeutic instrument.
 5. The method of claim 4, wherein the catheterhas a side opening adapted to pass the therapeutic instrument.
 6. Themethod of claim 1, further comprising the step of infusing anangiographic dye to confirm the reversal of blood flow.
 7. The method ofclaim 1, wherein the distal end of the catheter further comprises aradiopaque marker.
 8. The method of claim 1, wherein the firstconstricting member is a balloon.
 9. The method of claim 8, wherein thefirst constricting member is a toroidal balloon.
 10. The method of claim1, wherein the second constricting member is a balloon.
 11. The methodof claim 10, wherein the second constricting member is a toroidalballoon.
 12. The method of claim 1, further comprising the step ofinserting a third balloon to block the flow of emboli into a leftvertebral artery.